Emoxypine® (Solution, Drops) Instructions for Use
ATC Codes
C05CX (Other agents that reduce capillary permeability)
S01XA (Other ophthalmologicals)
Active Substance
Methylethylpiridinol (Grouping name)
Clinical-Pharmacological Group
Drug improving microcirculation. Angioprotector
Pharmacotherapeutic Group
Antioxidant agent
Pharmacological Action
Methylethylpiridinol inhibits platelet aggregation, reduces the overall coagulation index, and prolongs blood clotting time. It enhances the process of fibrinolysis. It reduces blood viscosity and decreases vascular wall permeability. It stabilizes the membranes of blood vessel cells and erythrocytes, increasing the resistance of erythrocytes to mechanical trauma and hemolysis. It possesses angioprotective properties. It improves microcirculation. It effectively inhibits free-radical lipid peroxidation of biomembranes and increases the activity of antioxidant enzymes. It stabilizes cytochrome P450 and has an antitoxic effect. In extreme situations accompanied by increased lipid peroxidation and hypoxia, it optimizes bioenergetic processes.
It increases the brain’s resistance to hypoxia and ischemia. In cases of cerebral circulation disorders (ischemic and hemorrhagic), it helps correct impairments of the peripheral nervous system function, facilitates the restoration of the brain’s integrative activity, and improves memory functions.
It dilates coronary vessels and reduces ischemic damage to the myocardium. In myocardial infarction, it limits the size of the necrosis focus, accelerates reparative processes, and promotes the normalization of myocardial metabolism. It has a beneficial effect on the clinical course of myocardial infarction by reducing the incidence of acute heart failure. It promotes the regulation of the redox system in circulatory insufficiency.
It possesses retinoprotective properties, protects the retina from the damaging effects of high-intensity light, promotes the resorption of intraocular hemorrhages, and improves ocular microcirculation.
Pharmacokinetics
After intravenous administration at a dose of 10 mg/kg, the T1/2 is 18 minutes; total clearance is 0.2 L/min; Vd is 5.2 L. It rapidly penetrates organs and tissues, where it is deposited and metabolized. Five metabolites of methylethylpiridinol have been identified, represented by dealkylated and conjugated products of its transformation. The metabolites of methylethylpiridinol are excreted by the kidneys. Significant amounts of 2-ethyl-6-methyl-3-hydroxypyridine phosphate are found in the liver.
After retrobulbar administration, Methylethylpiridinol appears in the blood almost instantly; its concentration decreases sharply during the first two hours, and after 24 hours, the active substance is absent from the blood. The concentration of methylethylpiridinol in eye tissues is higher than in the blood serum.
Indications
Used as part of complex therapy.
For intramuscular and intravenous administration: acute pancreatitis (during minimally invasive interventions under ultrasound guidance and laparoscopy); hemorrhagic stroke; ischemic stroke in the internal carotid artery basin and in the vertebrobasilar system; transient cerebral circulation disorders; chronic cerebral circulation insufficiency; traumatic brain injury accompanied by brain contusions; postoperative period in patients with traumatic brain injury operated on for epi-, subdural, and intracerebral hematomas combined with brain contusions; pre- and postoperative period in patients with arterial aneurysms and arteriovenous malformations of cerebral vessels; acute myocardial infarction, prevention of “reperfusion syndrome”; unstable angina.
For subconjunctival, parabulbar, or retrobulbar administration: subconjunctival and intraocular hemorrhage of various origins; retinopathy (including diabetic retinopathy); central and peripheral chorioretinal dystrophy; thrombosis of the central retinal vein and its branches; complications of myopia; angiosclerotic maculodystrophy (dry form); surgical interventions on the eyes, condition after surgery for glaucoma with choroidal detachment; dystrophic diseases of the cornea; trauma, inflammation, and burn of the cornea; protection of the cornea (when wearing contact lenses) and retina from the effects of high-intensity light (laser and solar burns, during laser coagulation).
ICD codes
| ICD-10 code | Indication |
| G45 | Transient cerebral ischemic attacks [TIAs] and related syndromes |
| H11.3 | Conjunctival hemorrhage (subconjunctival hemorrhage) |
| H16 | Keratitis |
| H18.4 | Corneal degeneration |
| H18.5 | Hereditary corneal dystrophies |
| H21.0 | Hyphema |
| H34 | Retinal vascular occlusions |
| H35.3 | Degeneration of macula and posterior pole |
| H35.4 | Peripheral retinal degenerations |
| H35.5 | Hereditary retinal dystrophies |
| H36.0 | Diabetic retinopathy |
| H52.1 | Myopia |
| I20.0 | Unstable angina |
| I21 | Acute myocardial infarction |
| I61 | Intracerebral hemorrhage (cerebrovascular accident of hemorrhagic type) |
| I63 | Cerebral infarction |
| I69 | Sequelae of cerebrovascular diseases |
| I72.9 | Aneurysm and dissection of unspecified site |
| K85 | Acute pancreatitis |
| Q28.2 | Arteriovenous malformation of cerebral vessels |
| S05 | Injury of eye and orbit |
| S06 | Intracranial injury |
| T26.1 | Burn of cornea and conjunctival sac |
| T90 | Sequelae of injuries of head |
| Z97.3 | Presence of spectacles and contact lenses |
| ICD-11 code | Indication |
| 8B00.Z | Intracerebral hemorrhage of unspecified site, unspecified |
| 8B10.Z | Transient ischemic attack, unspecified |
| 8B11 | Cerebral ischemic stroke |
| 8B22.40 | Arteriovenous malformation of cerebral vessels |
| 8B25.Z | Sequelae of cerebrovascular disease, unspecified |
| 9A61.5 | Conjunctival or subconjunctival hemorrhage |
| 9A70.Z | Hereditary corneal dystrophies, unspecified |
| 9A71 | Infectious keratitis |
| 9A78.4 | Corneal degeneration |
| 9A7Z | Diseases of the cornea, unspecified |
| 9A80 | Hyphema |
| 9B70 | Hereditary retinal dystrophies |
| 9B71.0Z | Diabetic retinopathy, unspecified |
| 9B74.Z | Retinal vascular occlusion, unspecified |
| 9B78.3Z | Degeneration of macula or posterior pole, unspecified |
| 9B78.4 | Peripheral vitreochorioretinal degenerations |
| 9D00.0 | Myopia |
| 9E1Y | Other specified diseases of the visual system |
| BA40.0 | Unstable angina |
| BA41.Z | Acute myocardial infarction, unspecified |
| BD51.Z | Aneurysm or dissection of unspecified artery |
| DC31.Z | Acute pancreatitis, unspecified |
| NA06.Z | Injury of eye and orbit, unspecified |
| NA07.Z | Intracranial injury, unspecified |
| NA0Z | Head injury, unspecified |
| NE00 | Burn of eye and adnexa |
| QB51.Y | Presence of other specified devices other than cardiac or vascular implants |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Solution
Doses and duration of the treatment course are determined individually, depending on the indications and dosage form.
Drops
Doses and duration of the treatment course are determined individually.
Instill 1-2 drops into the conjunctival sac 2-3 times/day. The duration of treatment is 3-30 days. If necessary and well tolerated, the treatment course can be extended up to 6 months or repeated 2-3 times a year.
Adverse Reactions
Possible agitation, drowsiness, increased blood pressure, reaction at the injection site (burning sensation along the vein, pain, itching).
Rarely headache, pain in the heart area; in individuals with chronic pathology of the digestive organs – nausea, discomfort in the epigastric region; in case of predisposition to allergic reactions, itching and redness of the skin may occur.
Local reactions: possible induration of paraorbital tissues.
Contraindications
Hypersensitivity; pregnancy, breastfeeding period; children and adolescents under 18 years of age.
With caution
For intravenous infusion: hemostasis disorders, during surgical operations, patients with symptoms of severe bleeding.
Use in Pregnancy and Lactation
Contraindicated for use during pregnancy and breastfeeding.
Pediatric Use
Contraindicated for use in children and adolescents under 18 years of age.
Geriatric Use
Use with caution in elderly patients to avoid the risk of exacerbation of chronic diseases.
Special Precautions
During treatment, it is necessary to constantly monitor blood pressure and blood coagulability.
Effect on the ability to drive vehicles and operate machinery
If drowsiness or changes in blood pressure occur after using methylethylpiridinol, patients should refrain from driving vehicles and engaging in other potentially hazardous activities. It should not be used by vehicle drivers while working.
Drug Interactions
α-Tocopherol acetate potentiates the antioxidant effect of methylethylpiridinol.
Methylethylpiridinol is not recommended to be mixed with other injectable agents in the same syringe.
Storage Conditions
Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.
Dispensing Status
Rx Only
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Solution for intravenous and intramuscular injection 30 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
| Emoxypine® | Solution for intravenous and intramuscular injection 30 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intravenous and intramuscular injection | 1 ml |
| Methylethylpiridinol hydrochloride (emoxypine) | 30 mg |
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (20) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (50) – cardboard packs.
1 ml – ampoules (5) – contour cell packaging (100) – cardboard packs.
Solution for intravenous and intramuscular injection 150 mg/5 ml: amp. 5, 10, 100, 250, or 500 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
| Emoxypine® | Solution for intravenous and intramuscular injection 150 mg/5 ml: amp. 5, 10, 100, 250, or 500 pcs. |
Dosage Form, Packaging, and Composition
| Solution for intravenous and intramuscular injection | 1 ml | 1 amp. |
| Methylethylpiridinol hydrochloride (emoxypine) | 30 mg | 150 mg |
5 ml – ampoules (5) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (1) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (2) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (20) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (50) – cardboard packs.
5 ml – ampoules (5) – contour cell packaging (100) – cardboard packs.
Eye drops 1%: bottle 5 ml with dropper cap
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
| Emoxypine® | Eye drops 1%: bottle 5 ml with dropper cap |
Dosage Form, Packaging, and Composition
Eye drops 1% in the form of a colorless or slightly colored, slightly opalescent liquid.
| 1 ml | |
| Methylethylpiridinol hydrochloride | 10 mg |
Excipients : anhydrous sodium sulfite – 2.5 mg, sodium benzoate – 2 mg, potassium dihydrogen phosphate – 5.4 mg, sodium hydrogen phosphate dodecahydrate – 6.5 mg, water-soluble methylcellulose – 6.5 mg, water for injections – up to 1 ml.
5 ml – glass bottles with a dropper cap (1) – cardboard packs.
Injection solution 10 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs.
Marketing Authorization Holder
Moscow Endocrine Plant FSUE (Russia)
Dosage Form
| Emoxypine® | Injection solution 10 mg/1 ml: amp. 5, 10, 100, 250, or 500 pcs. |
Dosage Form, Packaging, and Composition
| Injection solution | 1 ml |
| Methylethylpiridinol hydrochloride (emoxypine) | 10 mg |
1 ml – ampoules (5) – cardboard packs.
1 ml – ampoules (5) – plastic contour packaging (1) – cardboard packs.
1 ml – ampoules (5) – plastic contour packaging (2) – cardboard packs.
1 ml – ampoules (5) – plastic contour packaging (20) – cardboard packs.
1 ml – ampoules (5) – plastic contour packaging (50) – cardboard packs.
1 ml – ampoules (5) – plastic contour packaging (100) – cardboard packs.
Eye drops 1%: bottle 5 ml with dropper cap included
Marketing Authorization Holder
Pharmstandard-UfaVITA OJSC (Russia)
Dosage Form
| Emoxypine® | Eye drops 1%: bottle 5 ml with dropper cap included |
Dosage Form, Packaging, and Composition
Eye drops in the form of a transparent or slightly opalescent, colorless or slightly colored liquid.
| 1 ml | |
| Methylethylpiridinol hydrochloride | 10 mg |
Excipients : sodium sulfite – 3 mg, sodium benzoate (E211) – 2 mg, potassium dihydrogen phosphate – 5.4 mg, disodium hydrogen phosphate dodecahydrate – 6.5 mg, methylcellulose – 6.5 mg, water for injections – up to 1 ml.
5 ml – bottles of colorless glass (1) complete with a dropper cap – cardboard packs.
Ophthalmic drops 1%: bottle 5 ml
Marketing Authorization Holder
Emoxipharm, JSC (Russia)
Manufactured By
Ferment Firm, LLC (Russia)
Dosage Form
| Emoxypine® | Ophthalmic drops 1%: bottle 5 ml |
Dosage Form, Packaging, and Composition
Eye drops in the form of a colorless or slightly colored, slightly opalescent liquid.
| 1 ml | |
| Methylethylpiridinol hydrochloride (emoxypine) | 10 mg |
Excipients : anhydrous sodium sulfite, sodium benzoate, potassium dihydrogen phosphate, sodium hydrogen phosphate dodecahydrate, methylcellulose, water for injections.
5 ml – bottles of colorless glass (1) with a pipette – cardboard packs.
5 ml – bottles of colorless glass (1) with a dropper cap – cardboard packs.
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